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Jennifer A. Goldstein

Goldstein,JA_web image

Counsel

Washington, D.C.

T:
+1 202 414 9237 (Washington, D.C.)
F:
+1 202 414 9299 (Washington, D.C.)
E:
jgoldstein@reedsmith.com
Vcard

Jennifer is a member of the Life Sciences Health Industry Group (LSHI) in the Washington, D.C. office.  Her practice focuses on FDA regulatory matters.  Her experience includes matters involving drug safety, particularly risk evaluation and mitigation strategies, controlled substances, clinical investigations, Internet pharmacies, over-the-counter drug products, electronic records, and general compliance issues.  In addition, Jennifer has experience with other FDA regulated products, such as medical devices, foods, dietary supplements and cosmetics.  Prior to joining Reed Smith, Jennifer worked for six years in FDA’s Office of Chief Counsel as an Associate Chief Counsel for Drugs.  Prior to working at the FDA, she was an associate in the FDA practice of a prominent Washington, D.C. law firm.

Representative Matters

  • Advised clients on legal and regulatory requirements relating to the development and marketing of foods, dietary supplements, drugs, medical devices, cosmetics and consumer products.

  • Advised clients on the regulatory status of indirect and direct food additives, food packaging materials and medical devices.

  • Assisted clients in obtaining premarket approvals and clearances for products and advised clients on regulatory compliance issues affecting product development and marketing.

  • Counseled clients regarding regulatory, enforcement, legislative and litigation issues before federal agencies, including FDA, FTC, CPSC, as well as Congress, and federal and state courts.

  • Significant experience in evaluating compliance of product labeling, advertising, and Internet materials with applicable statutory and regulatory requirements.

Experience

2009 Reed Smith

Legal Education

1996 J.D., College of William and Mary, Marshall-Wythe School of Law

Undergraduate Education

1993 B.A., University of Virginia, Foreign Affairs

Professional Admissions / Qualifications

  • Virginia
  • District of Columbia

Professional Affiliations

  • District of Columbia Bar
  • Virginia State Bar (Associate Status)